Blog Home TAG: 21 CFR Part 11
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Best Practices for 21 CFR Part 11 Compliance

With more modern-day compliance enforcement, life science manufacturers and distributors are opting to digitize manual, paper processes with electronic transactions. Electronic records and [...]

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FDA Warning Letters Emphasize Document Control System Compliance

First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples.  Both [...]

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